83 FR 58598 - Importer of Controlled Substances Application: Janssen Pharmaceuticals Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 224 (November 20, 2018)

[Federal Register Volume 83, Number 224 (Tuesday, November 20, 2018)]
[Notices]
[Pages 58598-58599]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-25226]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Janssen 
Pharmaceuticals Inc.

ACTION: Notice of application.

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DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration on or before December 20, 2018. 
Such persons may also file a written request for a hearing on the 
application on or before December 20, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, 
Springfield, Virginia 22152. Comments and requests for hearings on 
applications to import narcotic raw material are not appropriate. 72 FR 
3417 (January 25, 2007)

SUPPLEMENTARY INFORMATION: The Attorney General has delegated his 
authority under the Controlled Substances Act to the Administrator of

[[Page 58599]]

the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority 
to exercise all necessary functions with respect to the promulgation 
and implementation of 21 CFR part 1301, incident to the registration of 
manufacturers, distributors, dispensers, importers, and exporters of 
controlled substances (other than final orders in connection with 
suspension, denial, or revocation of registration) has been redelegated 
to the Assistant Administrator of the DEA Diversion Control Division 
(``Assistant Administrator'') pursuant to section 7 of 28 CFR part 0, 
appendix to subpart R.
    In accordance with 21 CFR 1301.34(a), this is notice that on 
September 13, 2018, Janssen Pharmaceuticals Inc., 1440 Olympic Drive, 
Bldgs. 1-5 & 7-14, Athens, Georgia 30601-1645, applied to be registered 
as an importer of the following basic classes of controlled substances:

------------------------------------------------------------------------
         Controlled  substance           Drug code         Schedule
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Thebaine..............................         9333  II
Poppy Straw Concentrate...............         9670  II
Tapentadol............................         9780  II
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    The company plans to import an intermediate form of tapentadol 
(9780) to bulk manufacture tapentadol for distribution to its 
customers. The company plans to import thebaine (9333) derivatives as 
reference standards. The company plans to import concentrated poppy 
straw (9670) to bulk manufacture other controlled substances. No other 
activity for these drug codes is authorized for this registration.

    Dated: November 6, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-25226 Filed 11-19-18; 8:45 am]
 BILLING CODE 4410-09-P